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| Name | Class |
|---|---|
| Duke-NUS Graduate Medical School | OTHER |
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Liver resection has improved health outcomes in patients with hepatocellular carcinoma (HCC) in Singapore and worldwide. However, due to acute ischaemia/reperfusion injury (IRI) to the liver at the time of surgery, patients still experience significant morbidity and mortality. Therefore, novel therapies are required to protect the liver against acute IRI during partial hepatectomy. Remote ischaemic conditioning (RIC) using transient limb ischaemia/reperfusion has been shown to protect the liver in experimental animal studies. In the ERIC-LIVER trial the investigators investigate whether RIC can reduce liver injury and preserve liver function in patients with HCC undergoing partial hepatectomy.
Liver resection has improved health outcomes in patients with hepatocellular carcinoma (HCC) in Singapore and worldwide. However, due to acute ischaemia/reperfusion injury (IRI) to the liver at the time of surgery, patients still experience significant morbidity and mortality. Therefore, novel therapies are required to protect the liver against acute IRI during partial hepatectomy. Remote ischaemic conditioning (RIC) using transient limb ischaemia/reperfusion has been shown to protect the liver in experimental animal studies. In the ERIC-LIVER trial the investigators investigate whether RIC can reduce liver injury and preserve liver function in patients with HCC undergoing partial hepatectomy.
50 patients with HCC undergoing partial hepatectomy will be randomised to receive either RIC (four-5 minute arm cuff inflations/deflations) or sham control (four-5 minute arm cuff simulated inflations/deflations) after induction of anesthesia and prior to surgical incision. The primary endpoint of the study will be acute liver injury assessed by serum transaminases measured at 24 hours post-resection. Secondary endpoints will include liver function in subset of patients (N=24, assessed by indocyanine green [ICG] clearance measured at 24 hours post-resection), incid ence of liver failure, episodes of confirmed sepsis, acute kidney injury, intensive care unit and hospital stay, and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active RIC | Active Comparator | Active RIC using a manual BP cuff to inflate to 200mmHg. |
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| Sham Control | Sham Comparator | A sham control using a manual blood pressure cuff visually identical to that used in the RIC protocol will be placed on the upper arm and a simulated RIC protocol will be administered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active RIC | Device |
| ||
| Sham Control |
| Measure | Description | Time Frame |
|---|---|---|
| serum ALT (unit/L) following liver resection, measured at 24 hours | serum ALT as a measure of acute liver injury | 24 hours |
| serum AST (unit/L) following liver resection, measured at 24 hours | serum AST as a measure of acute liver injury | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| serum ALT (unit/L) following liver resection, measured at 6 hours | serum ALT as a measure of acute liver injury | 6 hours |
| serum ALT (unit/L) following liver resection, measured at 48 hours | serum ALT as a measure of acute liver injury |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Yao Teo | Contact | 63214515 | teo.jin.yao@singhealth.com.sg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore General Hospital | Recruiting | Singapore | 169608 | Singapore |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| 48 hours |
| serum ALT (unit/L) following liver resection, measured at 2 weeks | serum ALT as a measure of acute liver injury | 2 weeks |
| serum AST (unit/L) following liver resection, measured at 6 hours | serum AST as a measure of acute liver injury | 6 hours |
| serum AST (unit/L) following liver resection, measured at 48 hours | serum AST as a measure of acute liver injury | 48 hours |
| serum ALT (unit/L) following liver resection, measured at 2 weeks | serum AST as a measure of acute liver injury | 2 weeks |
| Indocyanine Green (ICG) retention test. | Liver function as assessed by the ICG retention test. Testing is optional | baseline in pre-admission clinic and post-operation day 1. |
| Acute liver ischemia reperfusion injury on histology | Assessed by checking liver histology of the resected specimen | up to 2 weeks |
| presence/absence of liver failure based on serum bilirubin and INR on post op day 5 | serum bilirubin and INR on post op day 5 | Baseline and day 5 post-surgery |
| Episodes of culture-confirmed sepsis | Episodes of culture-confirmed sepsis | 30 days |
| Serum creatine (umol/L) | Measure of acute kidney injury based on rise in serum creatine on day 3 post op | 3 days |
| ITU and hospital stay | ITU and hospital stay | Up to 30 days |
| Rate of hospital admission | Rate of hospital admission | 30 days |
| Mortality | Mortality | 30 days |
| D008107 |
| Liver Diseases |